The European Directorate for the Quality of Medicines & Healthcare highlighted the organization's achievements in 2017, including the first mAb monograph. / read more /
EMA recommended Novartis' Kymriah (tisagenlecleucel) and Kite's Yescarta (axicabtagene ciloleucel), chimeric antigen receptor (CAR) T-cell therapies, for approval in the European Union. / read more /
Plastic containers such as bottles and tubes, when combined with desiccants, such as silica gel canisters and packets, will often provide lower internal relative humidity for long time periods. / read more /
PDA reviews an industry survey of concerns and best practices regarding the EU GMP's required PUPSIT test for filters used in sterile filtration. / read more /
Increased use of single-use systems has led to a need to redefine safe, stable and integral systems for shipping biopharmaceuticals around the world. / read more /
This ebook covers novel technologies for the formulation, manufacture, purification, and delivery of sterile small- and large-molecule drugs, including single-use systems, facilities and equipment, contamination issues, and process analytics.
